Reported Aug 8, 2018 · Terminated
Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals Inc.…
Lupin Pharmaceuticals Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Lupin Pharmaceuticals Inc. · 111 S Calvert St Fl 21ST · Baltimore, MD · 21202-6174
Is this the product you have?
- Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only
- Manufactured forLupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States
- Manufactured by
Lupin Limited Pithampur (M.P.) 454 775INDIANDC 68180-422-01
- Lot codes and dates
Lot #: H800393Exp. 01/2020
- Amount recalled
- 13,896 bottles
Why it was recalled
Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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